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NCT02027584 Clinical Trial

Observational Study of Choline, Its Metabolites, and Phospholipids in Preterm Infants

Prematurity Clinical Trial

— NEO-CHOLIN  

Official title:
Supply of Term and Preterm Neonates With Choline, Lipids and Vitamines

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02027584
Other study ID # NEO-CHOLIN
Secondary ID
Status Completed
Phase N/A
First received December 20, 2013
Last updated January 2, 2014
Start date November 2008
Est. completion date July 2013

Study information
Verified date December 2013
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

To study concentrations of choline, its metabolites, and phospholipids in cord blood and remnants of clinically indicated blood samples

Description:

To collect cord plasma in preterm and term infants. To collect remnants of clinically indicated blood samples in parturients and hospitalized preterm infants during neonatal intensive care.

To determine concentrations of choline, its metabolites, and phospholipids by mass spectrometry.

To compare cord plasma concentrations with postnatal plasma concentrations.

Recruitment information / eligibility
Status Completed
Enrollment 414
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 6 Months
Eligibility Inclusion Criteria:

- meeting criteria of the 4 cohorts

Exclusion Criteria:

- none pre-defined

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• collection of remnant of clinically indicated blood sample
collection of remnant of clinically indicated blood sample

Locations
Country Name City State
Germany University Hospital Tuebingen Tuebingen

Sponsors (2)
Lead Sponsor Collaborator
University Hospital Tuebingen Universität Tübingen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Bernhard W, Full A, Arand J, Maas C, Poets CF, Franz AR. Choline supply of preterm infants: assessment of dietary intake and pathophysiological considerations. Eur J Nutr. 2013 Apr;52(3):1269-78. doi: 10.1007/s00394-012-0438-x. Epub 2012 Sep 9. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Concentration of choline in plasma at times when a clinically indicated blood sample is taken before discharge home from the initial neonatal hospitalization (at a postnatal age of up to 4-5 months at the most in very preterm infants) No
Secondary concentrations of choline metabolites at times when a clinically indicated blood sample is taken before discharge home from the initial neonatal hospitalization (at a postnatal age of up to 4-5 months at the most in very preterm infants) No
Secondary Concentrations of molecular species of phosphatidylcholine and phosphatidylethanolamine at times when a clinically indicated blood sample is taken before discharge home from the initial neonatal hospitalization (at a postnatal age of up to 4-5 months at the most in very preterm infants) No
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